Catalog Number 687549/JPB |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/16/2021 |
Event Type
malfunction
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Event Description
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The account alleges that during the hemodynamic monitoring of a patient, the dtx pressure monitoring [pm] set was found to be leaking fluid.No additional patient consequences to report.
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Manufacturer Narrative
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The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
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Manufacturer Narrative
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The suspect device has been returned for evaluation.The device was examined visually, and functional testing was performed.The complaint is confirmed.The root cause is attributed to the manufacturing process.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.
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Search Alerts/Recalls
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